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Pharma & Biotech

Immunic to present additional Phase 2 data on vidofludimus calcium in progressive MS

Immunic Inc (NASDAQ:IMUX) said it will present additional analyses from its Phase 2 CALLIPER trial of vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS) at the ACTRIMS Forum 2026, which is being held from February 5 to 7 in San Diego.

Vidofludimus calcium is described by Immunic as a nuclear receptor-related 1 (Nurr1) activator and selective dihydroorotate dehydrogenase (DHODH) inhibitor.

The company said the new data include magnetic resonance imaging (MRI) outcomes and immune analyses from a subset of trial participants. According to Immunic, MRI analyses showed reductions in markers associated with both acute and chronic inflammation compared with placebo.

The proportion of patients with gadolinium-enhancing lesions in the treatment group declined from 16.4% at baseline to 7% at week 72 and 0% at week 120, while the placebo group recorded 11.7% at week 72 and 2.9% at week 120. At week 72, 18.5% of patients receiving vidofludimus calcium had new or enlarging T2 lesions, compared with 30% in the placebo group.

The company reported statistically significant differences in mean T2 lesion volume changes at several time points, and a statistically significant difference in the number of slowly expanding lesions at week 96.

Immunic also said subset analyses from the trial showed reductions in Epstein-Barr virus (EBV)-specific T-cell receptor sequences, which the company said could indicate broad-spectrum antiviral effects.

“These latest findings from our Phase 2 CALLIPER trial provide additional evidence of vidofludimus calcium’s effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation,” Immunic CEO Daniel Vitt said in a statement.

“The findings further reinforce our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in multiple sclerosis (MS) patients."

Immunic’s chief medical officer Andreas Muehler noted that the MRI results showed reductions in markers of both acute and chronic inflammation in PMS patients.

"The observed reductions further support the potential of vidofludimus calcium to influence compartmentalized central nervous system inflammation, which is believed to contribute to disability progression, in this progressive patient population,” Muehler said.

The data will be presented in poster sessions at the conference.

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